Paper Conversion at Continuing Review e IRB Training

Paper Conversion at Continuing Review e. IRB Training - Summer 2006

Normal CR Process • Application has been submitted & approved • Continuing Review is required every 12 months (or other determined period) 2006 2007

Paper Conversion • Continuing Review Created • Application forms are filled out and submitted with the CR. They travel together through the review process.

Paper Conversion • Continuing Review is processed in e. IRB • When CR is completed, the Application goes fully active and is separated

Paper Conversion • Once the Application is fully active, all future subprojects (Amendments, Safety events and CRs ) will be electronic

Paper Conversion Click the Convert Paper Study Button to begin

Paper Conversion Fill out Step 1 with: -Short Study Title -Long Study Title -BG Number

Paper Conversion Step 2: Study Team *If you cannot find a study team member in appropriate the pick lists, use the provided link to go to the FAQ section and Request User Roles. You can add them to the application at a later time.

Paper Conversion When you click OK, a Continuing Review will appear in your inbox. Open it, click the Edit Forms button and follow the instructions to begin filling it out.

Paper Conversion

Paper Conversion

Paper Conversion This will take you to the first page of the application forms. Complete them as you would a normal application. Continue through the forms until you reach the end.

Paper Conversion

Paper Conversion This will take you to the Continuing review forms.

Paper Conversion

Paper Conversion Only the PI or Coordinator can submit the Continuing Review. When you submit, this will lock the CR forms and the Application forms for review.

Paper Conversion • You will be emailed about concerns like you are now in applications. Make sure to check both the CR forms and the Application forms for concerns to be addressed.

Paper Conversion • When your CR is approved, your study will become fully electronic. Some pieces of information may not be available in e. IRB (ie: Approval Letter) but all future subprojects will be electronic like any other active study.

Paper Conversion

CR in e. IRB • Implementation date: August 1, 2006 • All existing paper protocols must be in e. IRB by December 31, 2007 • Submit CR in e. IRB at least 30 days prior to the expiration date of the protocol • CR applications in e. IRB will have a new “effective date” (approval date)

CR in e. IRB • If a paper protocol expires (administratively closes), you must go into e. IRB and submit a NEW PROTOCOL APPLICATION –you will not be able to convert a paper protocol at that time. • If a study is in e. IRB for CR and has been reviewed by the board but is administratively closed before the “effective date, ” you have 30 days to respond to concerns before it will be withdrawn.

When you should not convert a paper protocol to e. IRB • If your study will close before Dec. 31, 2007 • If your study has been active for a number of years and no subjects have been enrolled – close it. If you choose to start this project again in the future, submit it as a new application in e. IRB

CR in e. IRB • Once a study is in e. IRB, you will be notified via email 60 days before the renewal date to submit a CR • If you do not submit the CR, you will receive another email at 30 days prior to the renewal date • Emails will go to the PI, Co-Is, Coordinator and other study team members!